Shanghai Mental Health Center
Shanghai, China
NCT Number: NCT07115615
This study will evaluate the decision-making ability and therapeutic effects of accelerated Transcranial Direct Current Stimulation (tDCS) as adjunct to pharmacotherapy in obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by EEG and MRI.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
Shanghai, China
The purpose of this study is to examine the decision-making ability and clinical efficacy of accelerated tDCS over orbitofrontal cortex (OFC) as adjunct to pharmacotherapy in treatment of OCD patients.60 OCD patients on stable medication will be randomized into two groups (i.e. active or sham stimulation). Accelerated tDCS stimulation will be performed four times a day, five times a week, for one week. Iowa Gambling Task will be conducted at the baseline, after the one week tDCS and at the 1-month follow-up to evaluate the decision-making ability of OCD patients.The investigators will assess symptom severity before and after one week of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale(Y-BOCS), Clinical Global Impression(CGI), the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory-II (BDI-II), the Beck Anxiety Inventory (BAI), Childhood Trauma Questionnair(CTQ), side-effect questionnaire and other scales will be obtained by a trained investigator.The patients will also receive magnetic resonance imaging (MRI) scan, electroencephalography (EEG).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode electrode will be localized in front of the right OFC on the Fp2 point according to the EEG international reference. Four anode electrodes will be placed around FP2 (i.e. Fpz, AFz, AF4, AF8)
To demonstrate the same stimulation sensation as under real conditions, only 40 seconds of real stimulation (2mA) are given at the beginning of the treatment. In the remaining 20 minutes, only about 15ms of short current pulses of 110uA occur every 550ms.
Time frame: Up to 5 weeks
The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.
Time frame: Up to 5 weeks
It is a 21-item self-report measure scored on a 4-point Likert-type scale to summarize recent symptoms of depression.
Time frame: Up to 5 weeks
It is a 21-item self-report inventory that is used for measuring the severity of anxiety.
Time frame: Up to 5 weeks
It consists of ten commonly-reported side effects as well as an "other" category that allows participants to describe experiences/sensations not otherwise covered to rate the intensity of side effects.
Contact information is provided by the study sponsor or research team.
Qing Wang, PhD
CONTACT
Qing Zhao, PhD,MD
CONTACT
Shanghai Mental Health Center
Other
Exploring the Efficacy of Accelerated Transcranial Direct Current Stimulation (tDCS) as Adjunct to Pharmacotherapy in the Treatment of Obsessive-compulsive Disorder: A Randomized Controlled Trial Using High-resolution MRI
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